European PRAC contraindicates use of Janssen COVID-19 Vaccine in people with history of capillary leak syndrome (CLS)

PRAC reviewed 3 cases of CLS, which occurred within 2 days of vaccination. One case had a history of CLS and two cases subsequently died. Healthcare professionals should be aware of signs and symptoms of CLS and risk of recurrence in people with previous history.

SPS commentary:

Patients with an acute episode of CLS following vaccination require prompt treatment and may require continuous specialist monitoring and intensive supportive therapy.

Healthcare professionals should tell people receiving the vaccine that they must seek medical attention if they have the following symptoms in the days after vaccination, which may be associated with feeling faint (due to low blood pressure): oedema in the extremities; sudden weight gain

The product information will be updated to include a contraindication in people with a history of CLS, and will be included as a side effect with an unknown frequency.


European Medicines Agency